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DINA – HITEX, spol. s r.o.

Active in EUDAMED

Czechiafrom SRN EUDAMED FDA SRN CZ-MF-000000312

Devices
870
Registrations
EUDAMEDFDA
FDA recalls
0

Catalogue870

Newest first, rows 301-350 of 870

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  • Surgical drapes Ref 10-0204-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH128

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-501-009-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 15-0107-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH691

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-803-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Vascular procedure pack Ref 303-007-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref 104-131-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-216-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-502-028-13-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 15720-PO

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 20-0103-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 51735-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH121

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Fixation elements Ref 70-0131-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref AR-108-009-21-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NR-201-005-26-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 501-254-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10856-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 18060-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 80-0108-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-20-0116-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 14522

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Absorbent towels Ref 50964

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 701-149-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Ophthalmological procedure pack Ref 201-171-U-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref DH032

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11745-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 30-0204-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NM-100-402 DH-NS

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 11-0446-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref XDFNR03

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH082

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH509

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 104-105-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 501-242-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns Ref 354553-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-011-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-222-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 71-0104-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 15-0105-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 50801-SMS 35g-HH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Vascular procedure pack Ref 505-013-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Caps Ref 12403

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-153-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Vascular procedure pack Ref 301-026-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref DH851

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref XDFLU06

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH309

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Isolation gowns Ref 30351

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 301-350 of 870

Showing 301-350 of 870

Company details

EUDAMED SRN
CZ-MF-000000312
SRN (system / procedure pack)
CZ-PR-000000561
EU VAT number
CZ 469 65 661
EUDAMED status
Active
EUDAMED registered name
DINA – HITEX, spol. s r.o.
Registered address
987, Ždánská, 68501, Bučovice, Czechia
PRRC contact
Shashidhar Singh(public in EUDAMED)

EUDAMED certificates7

7 certificates7 valid, 0 expiredMDR 7next expiry 10 Nov 2028

EUDAMED certificates (7)

3EC International a.s. 2265 7 certificates

  • 2023-MDR/QS-044 Active

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-049 Active

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-050 Active

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-051 Active

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-052 Active

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-053 Active Amended

    Quality management system EU MDR

    Issued
    9 Sep 2025
    Expires
    10 Nov 2028
    Reason
    Other
  • 2023-MDR/QS-054 Active Amended

    Quality management system EU MDR

    Issued
    20 Mar 2025
    Expires
    10 Nov 2028
    Reason
    Mnf data change

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • DINA-HITEX, spol. s r.o. Bucovice Vyskov · CZ FEI 3003767927

From the company website

Read 18 Oct 2026

We are DINA-HITEX, Czech leader in the production of disposable medical materials. We specialize in the production of complex operating covers and operating sets.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does DINA – HITEX, spol. s r.o. have in the registry?

The registry currently lists 870 devices for DINA – HITEX, spol. s r.o.. Devices recorded under merged duplicate company entries are counted once.

What EUDAMED certificates are recorded for DINA – HITEX, spol. s r.o.?

EUDAMED lists 7 certificates for DINA – HITEX, spol. s r.o. (quality management system) under MDR. 5 are recorded with the status issued. The most recent was issued on 9 Sep 2025.

Which FDA establishments are linked to DINA – HITEX, spol. s r.o.?

1 FDA establishment is linked to DINA – HITEX, spol. s r.o. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.